Sequential generalized likelihood ratio tests for vaccine safety evaluation
Article first published online: 25 AUG 2010
Copyright © 2010 John Wiley & Sons, Ltd.
Statistics in Medicine
Volume 29, Issue 26, pages 2698–2708, 20 November 2010
How to Cite
Shih, M.-C., Lai, T. L., Heyse, J. F. and Chen, J. (2010), Sequential generalized likelihood ratio tests for vaccine safety evaluation. Statist. Med., 29: 2698–2708. doi: 10.1002/sim.4036
- Issue published online: 20 OCT 2010
- Article first published online: 25 AUG 2010
- Manuscript Accepted: 9 JUN 2010
- Manuscript Received: 19 SEP 2009
- generalized likelihood ratio tests;
- sequential probability ratio test;
- vaccine safety
The evaluation of vaccine safety involves pre-clinical animal studies, pre-licensure randomized clinical trials, and post-licensure safety studies. Sequential design and analysis are of particular interest because they allow early termination of the trial or quick detection that the vaccine exceeds a prescribed bound on the adverse event rate. After a review of the recent developments in this area, we propose a new class of sequential generalized likelihood ratio tests for evaluating adverse event rates in two-armed pre-licensure clinical trials and single-armed post-licensure studies. The proposed approach is illustrated using data from the Rotavirus Efficacy and Safety Trial. Simulation studies of the performance of the proposed approach and other methods are also given. Copyright © 2010 John Wiley & Sons, Ltd.